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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES SCREW, BONE, 4 MM OD X 5.0 (127 MM) IN LG, STRIDE; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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BLUE BELT TECHNOLOGIES SCREW, BONE, 4 MM OD X 5.0 (127 MM) IN LG, STRIDE; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 101111
Device Problem Defective Component (2292)
Patient Problem No Patient Involvement (2645)
Event Date 09/06/2018
Event Type  malfunction  
Event Description
It was reported that a bone pin was found to be broken during sterilization.
 
Manufacturer Narrative
H10 h3, h6: the device, intended for use in treatment, was returned for evaluation.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.We were able to confirm if there was a relationship established between the reported event and the device.Visual inspection of the returned bone pin found that the threads were damaged and there was mechanical component failure.A factor that could have contributed to damaged threads is if the bone pin had been clamped.
 
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Brand Name
SCREW, BONE, 4 MM OD X 5.0 (127 MM) IN LG, STRIDE
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth, mn
MDR Report Key9998602
MDR Text Key189580871
Report Number3010266064-2020-00554
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 04/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number101111
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/13/2018
Initial Date Manufacturer Received 09/06/2018
Initial Date FDA Received04/24/2020
Supplement Dates Manufacturer Received07/10/2020
Supplement Dates FDA Received07/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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